Expanse Medical, Inc. · Class II · Cleared Jul 14, 2025
| K-number | K251488 |
| Device name | FLOWRUNNER Aspiration System |
| Applicant | Expanse Medical, Inc. |
| Product code | QEZ |
| Device class | Class II |
| Decision date | Jul 14, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.5150 |
The FLOWRUNNER Aspiration System is a peripheral thrombectomy device designed for minimally invasive removal of fresh, soft blood clots (emboli and thrombi) from peripheral arteries and veins. The system uses external vacuum suction applied to an aspiration catheter that is advanced through a sheath to directly target and remove clots from occluded vessels.
The FLOWRUNNER is substantially identical to the predicate ICE Aspiration System in materials, sterilization method (ethylene oxide), biocompatibility, shelf life (2 years), and intended use. Both are Class II embolectomy catheters for peripheral vasculature. The FLOWRUNNER comes in 12F and 14F diameters with lengths of 60cm, 80cm, 100cm, and 120cm. The system operates at maximum pressure of -27.6 inHg and minimum pressure of -8.0 inHg.
Not stated in this summary.
The predicate ICE Aspiration System (K234073) was identified as a valid comparator with identical intended use for peripheral embolectomy/thrombectomy. Bench testing demonstrated the FLOWRUNNER has compatible performance characteristics with no new safety or effectiveness concerns, including demonstrated compatibility with standard vascular implants like stents and filters. The FLOWRUNNER's design, materials, packaging, sterilization, biocompatibility, and shelf life are identical to the predicate, and it is offered in comparable sizes for the same clinical application, establishing substantial equivalence across all relevant parameters.
View the full FDA submission: accessdata.fda.gov